Indian syringes, catheters, implants, wound care and diagnostics are trusted worldwide. To sell them in Europe, you need CE marking under the Medical Device Regulation (EU) 2017/745. Most devices need a Notified Body, solid clinical evidence, an EU Authorised Representative and EUDAMED registration. PCN builds your MDR roadmap on top of your ISO 13485 and CDSCO work.
| Classes | I, IIa, IIb, III (only some Class I can self-declare) |
|---|---|
| QMS | ISO 13485-based quality system |
| Documentation | Annex II/III technical file, clinical evaluation, ISO 14971 risk, PMS/PMCF |
| EU AR | Mandatory for non-EU manufacturers |
| EUDAMED | Four modules mandatory from 28 May 2026 |
| Legacy devices | Transition extended to 2027/2028 by class, with conditions |
Only certain Class I devices.
Yes, as a non-EU manufacturer.
Four modules became mandatory on 28 May 2026.
Requirements, portals and fees change often. PCN confirms the applicable rules for each product before quoting. Certificates are issued by the relevant authority, accredited certification body or notified body.
Send your product name, HS code and destination. Our Delhi team will confirm the route, testing and timeline within 48 hours.
📞 +91 80109 05029 · ✉️ bdm@pcnindiaglobal.com
Related: EU Certification · US FDA · CDSCO (India)
One of India's leading independent consultancy bodies providing compliance, certification, and regulatory services to international and domestic players in electronics, IT, chemical, and electrical sectors.